Light therapy methods

ABSTRACT

An extra-oral light therapy device comprises a support that registers against features of a patient&#39;s head. A light source is mounted to the support. The light source may comprise an array of light emitting diodes (“LEDs”). A controller controls the extra-oral light therapy device. The support may comprise a tray fitted to the patient&#39;s teeth or a head-set fitted to the patient&#39;s ears and the bridge of the patient&#39;s nose. An external light therapy device has a thin, molded substrate, at least one array of light emitters mounted onto the thin, molded substrate, an attaching means for removably attaching the device to an area of treatment, and a controller for controlling the external light therapy device. Methods for supporting light sources adjacent desired treatment locations and for treating jaw bone disorders and jaw osteonecrosis and biostimulating bone and soft tissue are also disclosed.

REFERENCE TO RELATED APPLICATION

This application is a division of U.S. patent application Ser. No.11/767,302, filed Jun. 22, 2007, which is a continuation-in-part of U.S.patent application Ser. No. 11/355,583, filed Feb. 16, 2006, whichclaims the benefit of U.S. Provisional Application No. 60/705,753, filedon Aug. 5, 2005 and U.S. Provisional Application No. 60/653,828, filedFeb. 17, 2005, the contents of each of which is incorporated herein byreference in its entirety.

TECHNICAL FIELD

This invention relates to light therapy. Apparatus and methods accordingto the invention may be applied to the treatment of bone disorders andthe biostimulation of bone and soft tissue. Embodiments of the inventionprovide apparatus for irradiating tissues of the face and jaw withbiologically effective doses of light.

BACKGROUND

Light therapy involves irradiating tissues with light. Light canstimulate a variety of biological activities in cells and tissues thatare compromised in function. Light therapy treatment is typicallyadministered by a physician or therapist who directs light from ahand-held light emitting device at an affected area. Light emittingdevices can be difficult to position consistently over the affectedarea. Sometimes a tattoo is used to identify the affected area. However,even with a tattoo or other reference mark it is difficult toconsistently deliver light therapy treatments to an affected area.

Light therapy typically involves repeated treatments over at leastseveral days. Thus, patients undergoing light therapy may be required tomake multiple visits to a practitioner's office or clinic in order tocomplete a therapy regimen. Such repeated visits may be time consumingand/or expensive.

LEDs and other light sources suitable for generating light for lighttherapy can get hot when they operate. Such light sources can beinefficient at higher temperatures. Hot apparatus can also beuncomfortable or even dangerous to patients.

The inventor has identified a need or desire for light therapy apparatuswhich can deliver consistent treatments, particularly to tissues in thedental and maxillofacial areas. There is a particular need or desire forsuch apparatus that is sufficiently cost-effective and foolproof to beused at home by patients. There is also a need for such apparatus thatcan be operated without exposing a patient to high temperature surfaces.

SUMMARY

One aspect of this invention provides apparatus for delivering light totissues of a patient's dental and maxillofacial areas. The apparatuscomprises a support that registers against one or more anatomicalfeatures of a patient's head and one or more light sources mounted tothe support. The light sources illuminate selected tissues of apatient's dental and maxillofacial areas from outside of the patient'smouth. The light sources comprise arrays of LEDs in some embodiments.

In some embodiments the support comprises an intra-oral tray connectedto an extra-oral bridge. A light source, such as a light emitting diode(“LED”) array, is mounted to the extra-oral bridge.

In some embodiments, the support comprises a head-set that registers onthe bridge of a patient's nose and the patient's ears. A light source,such as a light emitting diode (“LED”) array, is mounted to thehead-set.

Other aspects of the invention provide methods for preparing lighttherapy apparatus and methods for delivering light therapy.

Further aspects of the invention and features of various exampleembodiments of the invention are described below and/or shown in theaccompanying drawings.

BRIEF DESCRIPTION OF DRAWINGS

The appended drawings illustrate non-limiting example embodiments of theinvention.

FIG. 1 is a view from the front side of an extra-oral light therapydevice having an intra-oral tray, an extra-oral bridge, and left andright side extra-oral LED arrays.

FIGS. 1A, 1B and 1C are respectively a cross-section, a front sideelevation and a rear elevation of a light source having a cooling fan, aheat sink and two arrays of light emitters.

FIG. 2 is a right side view of the device of FIG. 1 with the end of theextra-oral bridge attached to the extra-oral LED array.

FIG. 3 is a view from the front-left side of the extra-oral bridge,intra-oral tray and extra-oral LED array of FIG. 1.

FIG. 4 is a view from the rear right side of the extra-oral bridge,intra-oral tray and extra-oral LED array of FIG. 1.

FIG. 5 is a view from the left rear side of the extra-oral bridge,intra-oral tray and extra-oral LED array of FIG. 1 with the intra-oraltray detached.

FIG. 6 is a top view of a programmable controller for use with lighttherapy apparatus.

FIG. 7 is a perspective view of a light therapy device according to analternative embodiment in which an LED array is supported by a head-set.

FIG. 7A is a perspective view of a light therapy device according toanother alternative embodiment in which an LED array is supported by ahead-set.

FIG. 8 is a side view of the light therapy device of FIG. 7.

FIG. 9 is a front view of at least one LED array, and a connectordetached from the head-set.

FIG. 10 is a front view of an external light therapy device having twoLED arrays, a hinge-like member, and an attaching means.

FIG. 11 is a cross-sectional view of an LED array mounted onto asubstrate.

FIG. 11A is a schematic cross section through a portion of a lightsource having a light emitter and a reflector.

FIG. 12 is a cross-sectional view of an LED array detached from thesubstrate.

DESCRIPTION

Throughout the following description specific details are set forth inorder to provide a more thorough understanding to persons skilled in theart. However, well known elements may not have been shown or describedin detail to avoid unnecessarily obscuring the disclosure. Accordingly,the description and drawings are to be regarded in an illustrative,rather than a restrictive, sense.

FIG. 1 shows an example light therapy apparatus 2 that comprises anextra-oral light source 4 having a right side 1 and a left side 3 (asviewed from the front of the device), an extra-oral bridge 5, and anintra-oral tray 7. Intra-oral tray 7 registers to a patient's teeth.Light source 4 is rigidly connected to intra-oral tray 7 by extra-oralbridge 5. Therefore, a patient can position light source 4 accuratelyand repeatedly to illuminate a desired location in the patient's dentaland maxillofacial areas by inserting intra-oral tray 7 into his or hermouth and biting intra-oral tray 7 so that it registers to at least someof the patient's teeth. This stabilizes light therapy apparatus 2 andpositions light source 4 at a desired position. The consistent alignmentand targeting of light from light source 4 during subsequent treatmentsmakes the treatments more repeatable.

In the illustrated embodiment, extra-oral bridge 5 is removable fromextra-oral light source 4 and intra-oral tray 7. Providing a lighttherapy apparatus 2 having major components that are detachablyconnectable to one another adds versatility. A design which permits themajor components of the light therapy apparatus to be disassembled andreassembled while preserving alignment of extra-oral light source 4 tointra-oral tray 7 has the advantage that the apparatus can bedisassembled for storage or transportation and then used immediatelyafter assembly. FIG. 3 shows light therapy apparatus 2 with extra-orallight source left side 3 detached from extra-oral bridge 5.

Extra-oral bridge 5, extra-oral light source right side 1, andextra-oral light source left side 3 may be secured together via asuitable connector. For example, extra-oral bridge 5, the extra-orallight source right side 1, and the extra-oral light source left side 3may be connected by inserting male connector portions 6A of theextra-oral light source right and left sides 1 and 3 into correspondingfemale connector portions 8A of extra-oral bridge 5 (see FIG. 3).Suitably, the suitable connector allows extra-oral light source rightand left sides 1 and 3 to be detached from extra-oral bridge 5 for easeof use and flexibility.

In some embodiments, extra-oral light source right and left sides 1 and3 are rotatable between a sagittal orientation (as shown in FIG. 1) anda vertical orientation (indicated in dotted outline in FIG. 1). Lightsource right and left sides 1 and 3 can be locked at a desired angle ofrotation by any suitable mechanism. This permits light source right andleft sides 1 and 3 to be arranged so that the light that they emit fullycovers the desired treatment areas.

Intra-oral tray 7 may be connected to extra-oral bridge 5 by way ofanother suitable connector. In the embodiment illustrated in FIG. 5, amale portion 6B of intra-oral tray 7 is removably received in a femaleportion 8B of extra-oral bridge 5. Where intra-oral tray 7 is removablefrom extra-oral bridge 5, extra-oral bridge 5 may be reused for otherpatients (after suitable sterilization). Intra-oral tray 7 may bedisposed of after it is no longer required by a patient. In someembodiments, extra-oral bridge 5 is non-removably attached to intra-oraltray 7.

Intra-oral tray 7 is intended for insertion into a patient's mouth andis suitably shaped to fit around a patient's teeth. Intra-oral tray 7may register with a few selected teeth (for example, intra-oral tray 7may comprise a bite tab) or may fit around the patient's full set ofteeth. In one embodiment, the intra-oral tray 7 comprises a frame of aplastic or other suitable material that can serve as a skeleton for asettable material. The frame may be perforated to aid retention of thesettable material. The frame may comprise extra-oral bridge 5 or aconnector to connect to extra-oral bridge 5.

Prior to being used in the delivery of light therapy, the frame forintra-oral tray 7 may be filled with a suitable settable material (forexample a clear vinyl siloxane gel or similar material) which setsaround the patient's teeth and subsequently allows repeatable alignmentof intra-oral tray 7 in the patient's mouth. Where intra-oral tray 7could be in the path of light as it travels from light source 4 totarget tissues, the material of intra-oral tray 7 should be transparentto the light.

Extra-oral bridge 5 preferably conforms around the jaw line of apatient. The light source right and left sides 1 and 3 are respectivelypositioned on the right and left sides of a patient's face along thepatient's jaw line. Extra-oral bridge 5 may be adjustable to permitalignment of light source left and right sides 1 and 3 with target areasto be irradiated. Light source left and right sides 1 and 3 areextra-oral (outside of the patient's oral cavity). Light can pass fromleft and right sides 1 and 3 through tissues of the patient's lips andcheeks into target areas on the patient's gums and/or in the patient'sjaws.

Light source 4 emits light toward the patient. The light is notnecessarily visible light. For example, the light may include or consistof infrared light. Light source 4 comprises an array of light-emittingdiodes (LEDs) in some embodiments. Light source 4 has an inner surface13 (see FIG. 4) that is placed near or against the patient's skinadjacent to the tissues that it is desired to treat. Light is emitted isfrom inner surface 13 toward the area of treatment. In some embodiments,left and right sides 1 and 3 of light source 4 each have a lengthsimilar to a significant fraction of the length of a human jaw. Forexample, left and right sides 1 and 3 may each have a length of about 20mm to about 90 mm in some embodiments and about 25 to about 45 or 60 mmin some embodiments. In cases where a light source 4 is intended totreat a localized condition, then light source 4 may be smaller inextent. In some embodiments, light source 4 has optics that emit lightin the form of diverging beams. In such cases, light source 4 may besomewhat smaller than the area of tissues to be treated because lightfrom light source 4 will spread somewhat as it passes through thetissues of the patient's lips and cheeks before reaching the tissues ofthe jaw and or gums to be treated.

Light source 4 may be wide enough to illuminate both upper and lowerjaws of a patient simultaneously although in some embodiments lightsource 4 may be narrower. For example, light source 4 has a width in therange of 12 mm to about 40 mm in some embodiments (e.g. about 15 to 17mm in some embodiments).

In some embodiments, the light is emitted by arrays of discrete LEDs.The LEDs may be arranged in any of a wide variety of patterns. Forexample, the LEDs may be arranged in staggered parallel rows to maximizethe density of LEDs in the LED array. The LEDs may be arranged toachieve substantially uniform optical intensity over the light-emittinginner surface 13 of light source 4. In some embodiments, each arraycomprises 50 to 100 LEDs or other light emitters.

It is desirable that the average light intensity produced by lightsource 4 is at least about 10 mW/cm². In some embodiments, light source4 has an average intensity that is, or can be adjusted to be, in therange of 20 mW/cm² to about 60 mW/cm². In some embodiments the output oflight source 4 is pulsed. In such embodiments, the peak light intensitymay be significantly higher than 50 mW/cm².

In some embodiments right light source 4 or its components are flexibleso that they can be bent in one or two dimensions (i.e. molded) toconform to the contours of the patient's face. For example, light source4 may comprise an array of light emitters mounted to a flexible sheet ofmaterial that will hold a shape when it is bent. The flexible materialcan advantageously comprise a metal sheet that can serve as a heat sinkor as a thermal path to a heat sink for heat generated by the lightemitters. The flexible sheet may be molded to conform to the contours ofthe patient's face while light therapy apparatus 2 is being fitted.

Light source 4 may include optical elements such as lenses andreflectors to focus and direct light from light source 4 onto a targetarea. Such optical elements may be suitably encapsulated in plastic orsimilar material. FIG. 11A shows a portion of a light source 4. A lightemitter 11 (which may, for example, comprise a junction in alight-emitting diode or other light-emitting semiconductor device) islocated adjacent to a reflective backing 11A. A curved light-reflectingrecess 11B is provided adjacent to light emitter 11. Light from lightsource 11 is reflected in recess 11B to form a beam. The beams from alllight emitters of light source 4 combine to illuminate the targettissues. The area covered by the beam will depend upon the tissues whichit is desired to treat. In some embodiments, the beams of light emittedby light source 4 diverges to cover an area of tissue larger than thearea of the light-emitting part of light source 4. In other embodimentsthe emitted light converges to provided increased light intensity at thelocation of the tissues that it is desired to treat. In someembodiments, the emitted light diverges in a beam having an includedangle ÿ in the range of about 45-60°.

Since LEDs and other light emitters give off heat when they areoperated, it is desirable to provide a suitable mechanism fordissipating the heat to prevent any parts of light therapy apparatus 2that could come into contact with a patient's skin from getting too hot.For example, light source 4 may comprise a system for forced air orliquid cooling. A cooling system allows for treatment without the dangerof potential burns to the patient and allows for greater efficiency andcontrol of the device.

Extra-oral light source right and left sides 1 and 3 may comprisethermally-conductive LED wafers mounted on a suitable heat sink. Heatfrom the LED wafers is conducted into the heat sink and dissipated.FIGS. 1A, 1B and 1C show a light source 100 of a type that may be usedas light source right and left sides 1 and 3. Light source 100 comprisesarrays 102 of LEDs that are mounted to a heat sink 104. Heat sink 104has pins 106 projecting from its face that is away from LED arrays 102.A fan 110 causes air to flow past pins 106 to carry away excess heat.

To be most effective, the light from light source 4 at the tissues to betreated should have at least a threshold intensity. Light source 4 maybe operated in a pulsed mode to facilitate cooling of light source 4while ensuring that when light source 4 is emitting light, the intensityof emitted light at the tissues to be treated is sufficient to beeffective. In some embodiments, the duty cycle of light source 4 is 1:1or less, in some embodiments 1:2 or less (for each interval in whichlight source 4 is on, light source 4 is off for two equal intervals).The pulsing of light source 4 may be performed fast enough that lightsource 4 does not visibly flicker (e.g. at 25 Hz or more) although thisis not mandatory.

While the invention is described herein as usefully employing LEDs,other light sources such as lasers could suitably be employed. Thecharacter of the light emitted by light source right and left sides 1and 3 will depend upon the nature of the LEDs or other light emitters inlight source 4. It is generally desirable that the emitted light includelight in the wavelength range of 620 nm to 1000 nm. In some embodimentsthe emitted light includes light having a wavelength in at least one ofthe following wavelength ranges: about 820 to about 890 nm and about 620to about 680 nm. Light having wavelengths corresponding to one or moreof the following ranges may be particularly effective:

613 nm to 624 nm

667 nm to 684 nm

750 nm to 773 nm

812 nm to 846 nm.

The range 613 nm to 624 nm corresponds to a band at which reducedcytochrome c oxidase absorbs light. The range 812 nm to 846 nmcorresponds to a band at which oxidized cytochrome c oxidase absorbslight.

The light is substantially monochrome in some embodiments although thisis not mandatory. Providing light emitters that emit at multiplewavelengths allows for irradiation over multiple wavelengths for greaterbiological activity. The light may comprise incoherent light althoughthis is not mandatory. The light may be delivered continuously or pulsedat suitable frequencies and duty cycles.

Invisible infrared light can be clinically effective. In someembodiments in which the emitted light includes infrared light, theemitted light also includes bright visible light. The bright visiblelight deters users from looking into the light source when it isoperating, provides a perceptible indication that the apparatus isoperating, and may be useful in properly positioning the device. Thevisible light may be, but is not necessarily in a wavelength range thatis beneficial for light therapy. In some embodiments, the ratio of theintensities of the visible and infrared components of the light is 1part or less visible light to 5 parts or more infrared light.

The treatment area and desired light characteristics will vary frompatient to patient. A physician, dentist or other therapist candetermine a light treatment regime for a patient and set up lighttherapy apparatus 2 to operate light emitters in light source 4 toprovide the desired treatment.

FIG. 6 illustrates a programmable controller 15 of a type that may beused to control the operation of light therapy apparatus 2 (or otherlight therapy apparatus as described below). Programmable controller 15may be a separate, remote unit or may be directly connected to orintegrated with light source 4. Programmable controller 15 may comprisea microprocessor, data store, power supply, clock and associatedelectronic circuitry. Control parameters are stored in the data store.Programmable controller 15 operates light source 4 according to theparameters in the data store. The parameters may specify one or more of:

-   -   treatment duration;    -   light intensity during the treatment;    -   whether light emitters operate continuously or are pulsed;    -   if the light emitters are pulsed, the rate at which light        emitters are pulsed;    -   if the light emitters are pulsed, the duty cycle at which the        light emitters are pulsed;    -   etc.

If light therapy apparatus has sets of light emitters having differentcharacteristics (e.g. sets of LED that emit light at differentwavelengths or sets of light emitters that illuminate target tissues indifferent locations) then separate control parameters may be providedfor different sets of the light emitters. In some embodiments, differentsets of parameters are specified for different segments (intervals) of alight treatment. For example, light therapy treatments may be definedfor a set of intervals each lasting from a few seconds to a few hundredseconds or a fraction of an hour. Different parameters may be specifiedfor each of the intervals. The intervals are not necessarily equal inlength.

In some embodiments, different sets of parameters may be specified fordifferent areas of light source 4. In some cases, some areas of lightsource 4 may be turned off because the treatment plan for a patient doesnot require light to be delivered at locations corresponding to thoseparts of the light source 4.

A physician, dentist, or therapist may program a patient's treatmentregimen into programmable controller 15. This may be done, for example,with the aid of suitable software running on a computer that is in datacommunication with programmable controller 15 or by way of a suitableuser interface built into programmable controller 15.

Programmable controller 15 may have one or more pre-set programs builtin. As an alternative to, or as an aid to programming controller 15 thephysician, dentist, or therapist may select a pre-set program that isappropriate for controlling light therapy apparatus 2 to deliver lightto a patient.

A typical treatment regimen provides a dose of light daily. Each of thedaily doses of light may be delivered over a period lasting between afew minutes and an hour or so. For example. the inventor has found thatdaily ½ hour doses of light can be effective and are not undulyinconvenient for patients. A single daily dose appears to be aseffective as dividing the same dose into multiple sessions delivered atdifferent times during the day. Examples of possible treatment regimensare

-   -   Enhancement of bone density by applying light in 5 treatments        per week for 12 weeks. Each treatment lasts ½ hour and        illuminates the tissues of a patient's jaw with light having        wavelengths of 660 nm and 840 nm. The 660 nm light has an        intensity of about 20 mW/cm² at the skin's surface The 840 nm        light has an intensity of about 10 mW/cm² at the skin's surface.    -   Accelerating healing of bone grafts by applying light in daily        treatments for 21 days. Each treatment lasts between 20 minutes        and one hour and illuminates the tissues of a patient's jaw with        light having a wavelength of 618 nm and an intensity of 20        mW/cm² at the skin's surface.

Programmable controller 15 may maintain a log of treatments that havebeen delivered. For example, controller 15 may log the date and timethat each treatment was initiated, the duration of the treatment, andwhether or not the treatment was completed. This log can be subsequentlyreviewed by a dentist, physician, or the like to evaluate whether or notthe patient has complied with the prescribed treatment regimen.

Programmable controller 15 has a button or other suitable user patientinterface that allows a patient to initiate a treatment according topreviously-set parameters in the data store. The patient interface ispreferably very simple such that minimal instruction is required toexplain to a patient how to use light therapy apparatus 2. Programmablecontroller 15 may include an audible or visual indicator that generatesa signal to remind a patient that it is time for a treatment (or that ascheduled treatment is overdue).

A patient can use light therapy apparatus 2 at home or in anotherlocation by operating programmable controller 15 to initiate delivery ofa treatment.

Programmable controller 15 may comprise circuitry that monitorstemperature at one or more locations in light source 4. The circuitrymay monitor a signal modulated by a temperature sensor in light source4. In the alternative, programmable controller 15 may monitor thecurrent and voltage driving LEDs in light source 4. The current/voltagerelationship is temperature-dependent. Thus, by monitoring thecurrent/voltage relationship programmable controller 15 can determinewhether the LED is at an undesirably high temperature. Programmablecontroller 15 may shut off or reduce current to light source 4 (or partof light source 4) when it detects that the temperature of light source4 is undesirably high (or is trending towards being undesirably high).If light source 4 is equipped with a cooling fan then programmablecontroller 15 may optionally control the speed of the cooling fan inresponse to the monitored temperature.

Programmable controller 15 may be configured to maintain a log oftreatments delivered by light therapy apparatus 2. The log may bereviewed by a physician, dentist or technician to verify that lighttherapy device has been used as prescribed by a patient. The log maytrack the times and durations of light therapy treatments delivered bylight therapy apparatus 2 and may also track other features such asoperating temperatures, operational status and the like.

FIGS. 7 and 8 show a light therapy apparatus 2A having a head-set stylearrangement. Light therapy apparatus 2A comprises a head-set 17 and atleast one extra-oral light source 19 mounted to head-set 17 by way of asuitable connector 21. Head-set 17 may have the general form of a framefor eyeglasses. In the illustrated embodiment, headset 17 has arms 27that fit above and around the patient's ears and a frame 29 that fitsover the bridge of the patient's nose. Head-set 17 may also includelenses (not shown). Suitably, the lenses may be made of a material thatblocks radiation at wavelengths emitted by light source 19 so that thepatient's eyes are protected from the radiation. Light source 19 maycomprise an array of LEDs or other light emitters.

When head-set 17 has been adjusted to fit an individual patient, frame29 registers with the bridge of the patient's nose and arms 27 sit onthe patient's ears. Head-set 17 will sit on the patient's head in thesame way each time it is put on. Head set 17 may be adjusted for fit byadjusting arms 27 which may be made of a firm, resilient material thatallows for some flexibility for a better and more secure fit forindividual users. In some embodiments, arms 27 can also be adjustedhorizontally along their axis. Frame 29 can also be adjustable, forexample, by bending to allow for a better and more secure fit. Anelastic keeper such as an elastic strap may be provided to hold head-set17 in place during use.

In the embodiment shown in FIG. 7A, connector 21 permits the position oflight source 19 to be adjusted both along a horizontal axis 30A and avertical axis 30B relative to head-set 17. A yoke 31A is mounted tohead-set 17 by screws 31B which pass through slot 31C. The position oflight source 19 in horizontal direction 30A can be adjusted by looseningscrews 31B, sliding yoke 31A to a desired position along slot 31C andretightening screws 31B. Light source 19 is connected to arms 31D ofyoke 31A by screws 31E which pass through slots 31F. The verticalposition of light source 19 may be adjusted by loosening screws 31E,sliding light source 19 up or down along slots 31F to a desired verticalposition and then retightening screws 31E.

In the illustrated embodiment slot 31C is curved when viewed from above.Slot 31C generally follows the curvature of a typical maxillary bonesuch that light source 19 can effectively be applied against thepatient's skin for a range of positions of light source 19 along slot31C. Since the lower portions of people's faces are typically narrowerthan upper portions, connector 21 may hold light source 19 so that it istilted with its lower edge projecting more in the direction of thepatient than its upper edge. In some embodiments the angle of tile oflight source 19 is adjustable. Head-set 17 may be adjusted so that lightsource 19 is biased against the patient's face when head set 17 is beingworn by a patient.

Many alternative designs for connector 21 may be provided. For example,connector 21 may comprise a bar, rod or similar device that can beclamped or otherwise fastened to head-set 17 and a clip or similarmechanism that fastens light source 19 to the bar, rod or similardevice.

As shown in FIG. 9, in some embodiments light source 19 can be removablydetached from head-set 17. This can be convenient for storage ortransportation of light therapy apparatus 2A.

In another embodiment, head-set 17 comprises an adjustable strap (notshown) which fits around the crown of a patient's head for securing theextra-oral light therapy device 2A. The adjustable strap can also fitaround a patient's chin and extend back to the crown and around thecrown of a patient's head. The adjustable strap may be made of aflexible, elastic woven material.

FIG. 10 shows a light therapy apparatus 34 comprising at least one lightsource 35. Light source 35 comprises at least one light emitter, forexample an LED array, mounted on a thin molded substrate 51 (FIG. 11).More than one array of light emitters may be provided in light source35. For example, the light source 35 shown in FIG. 10 has two arrays ofLEDs. Arrays 36 of light emitters may be arranged in lower level 45 andan upper level 47. The upper and lower levels may be separatelycontrolled. The upper and lower levels respectively irradiate tissues ofthe upper and lower jaws. An attaching means 43 is provided for securingthe device to the area of treatment.

A power source and controller, which may comprise a programmablecontroller 15 as described above, operate light source 35 to emit lightaccording to a desired protocol.

In the example apparatus 34 shown in FIG. 10, light source 35 has aright section 37, a center section 39 and a left section 41. Rightsection 37 and the left section 41 are respectively supported on theright and left sides of a patient's face. A light source 35 as shown inFIG. 10 may be supported by way of any suitable attaching meansincluding:

-   -   a head-set 17 as described above;    -   an intra-oral tray 7 which may comprise a full tray or one or        more bite tabs as described above;    -   an adhesive such as double-sided adhesive tape;    -   a strap or set of straps; or    -   the like.

The LED arrays may be removably attached to light source 35 by suitableconnectors 38 such as ribbon connectors or may be more permanentlyintegrated into light source 35 as illustrated in FIG. 11. Providingremovable, repositionable LED arrays on a light source 35 permits LEDarrays to be arranged on light source 35 so as to optimally illuminatetarget tissues. LED arrays may be concentrated to illuminate targettissues while areas of light source 35 that overly non-target tissues donot need to have any LED arrays.

FIG. 12 shows a cross-section of an LED array 36 of external lighttherapy device 34 detached from substrate 51. A clip or similarattaching means 53 allows the at least one LED array 36 to be mountedonto substrate 51. Substrate 51 serves as a heat sink as describedabove. Substrate 51 may be made of aluminum or similar metal that is agood heat conductor. Substrate 51 may be moldable (i.e. flexible in oneor two dimensions so that it can be formed to follow contours of apatient's face and, once formed, will retain its shape).

Hinge-like members 49 may be provided between arrays 36 to allow lightsource 35 to be bent to provide a better fit around the facial area.Hinge-like member 49 may comprise a thin crease 50 or other bend lineset into the substrate material, as illustrated in FIG. 11. Hinge-likemember 49 allows the center section 39 to fit around a patient's mouthand the right section 37 and the left section 41 to fit around apatient's face.

Apparatus as described herein may be applied to treat a variety ofconditions including:

jaw osteonecrosis,

other jaw bone disorders,

periodontitis,

malocclusion and other conditions treated by orthodontics,

stimulation and acceleration of healing after oral surgery orperiodontal surgery,

stimulation of the healing of wounds at the locations of bone grafts,

healing and acceleration of osseo-integration of endosseous dentalimplants; and,

the like.

The application to jaw osteonecrosis permits treatment of a conditionfor which existing treatments are highly invasive. Treatingosteonecrosis using light therapy is significantly more cost-effectiveand comfortable for the patient than existing surgical treatmentoptions.

The apparatus may be applied by fitting a support to a patient. Thesupport may comprise a head-set, intra-oral tray, a bite tab, or thelike. When the support has been fitted so that it can be repeatably wornby the patient one or more light sources are mounted to the support atlocations where light from the light sources can illuminate a treatmentarea. A treatment regimen is then established. The physician, dentist,or therapist at his office or a patient at his home then performs theprescribed extra-oral light therapy treatment.

An example method for treatment for jaw osteonecrosis, other jaw bonedisorders, periodontitis, orthodontics, or for stimulation andacceleration of healing after oral surgery or periodontal surgery or foracceleration of osseo-integration of endosseous dental implants appliesextra-oral light therapy device 2. Prior to extra-oral light therapytreatment, intra-oral tray 7 is prepared by filling it with a suitablesettable material such as a clear vinyl siloxane gel or similarmaterial. The intra-oral tray is then placed around the patient's teethto obtain an impression of the patient's teeth. After the settablematerial sets, intra-oral tray 7 can be used to achieve consistenttargeting of light to target tissues bone during subsequent treatments.

A physician, dentist, or therapist programs a patient's prescribedtreatment regimen into a programmable controller 15 (see FIG. 6, forexample). Programmable controller 15 controls parameters of a lighttherapy treatment to be delivered by light therapy apparatus 2. Forexample, controller 15 may control the duration of the treatment, lightintensity, pulse frequency, etc. Programmable controller 15 runs apatient's prescribed treatment regimen causing the at least one lightsource 4 to emit pulsed or continuous light according to the prescribedparameters onto the treatment area. Therefore, stimulating andaccelerating bone formation and healing at a patient's treatment areafor the treatment of jaw bone disorders and jaw osteonecrosis.

The invention also relates to a method for the treatment and stimulationof soft and hard tissue and the biostimulation of bone. In this method,a light source 35 which may comprise at least one LED array 36 is firstattached to the desired area of treatment. A physician, dentist, ortherapist programs a patient's prescribed treatment regimen into aprogrammable controller 15. Programmable controller 15 controls theenergy density, pulse frequency and duration of the external lighttherapy device 34. The programmable controller 15 runs a patient'sprescribed treatment regimen causing the at least one LED array 35 toemit pulsed or continuous light at the predetermined rates andfrequencies onto the treatment area. The light therapy device canprovide effective, stabilized, repeatable, accurate, programmable, andconsistent light therapy for the treatment and stimulation of soft andhard tissue and the biostimulation of bone.

Several studies have been carried out to determine the effectiveness ofthe invention. In one, a retrospective record review of a cohort of 68QUS (quantitative ultrasound) scanned dental patients from the privatepractices of two co-investigators as performed. All scans and treatmentsoccurred between 2002 and 2005. Inclusion criteria included: 1) nosurgical procedure at an investigative site during or less than one yearprior to entry into the study; 2) pre-treatment and post-treatment QUSscans of the maxillofacial region; 3) LED therapy to one or moremaxillofacial regions. Exclusion criteria included: 1) a medicalcondition associated with abnormal bone growth or remodeling, such asPaget's disease of bone, fibrous dysplasia, osteopetrosis, severesystemic osteoporosis, etc.; 2) unwillingness to sign informed consentform; 3) inability to perform daily LED treatments at home; 4) inabilityto obtain high quality QUS scans of the jaws. An exclusion waiver forthe research was provided by the Committee for the Protection of HumanSubjects of the University of Texas in Houston and informed consent wasobtained from all subjects.

QUS scans were made immediately prior to LED therapy and immediatelythereafter. All scans were performed by the FDA cleared dental QUSdevice, the Cavitat 4000™ (Cavitat Medical Technologies, Inc, Aurora,Colo.). This device renders a series of 3-dimensional cube images fromanalog signals generated when an external transmitter sends 27,000 soundpulses per microsecond through the alveolar bone at a speed of 317.6meters per second, 3.5 mHz, to an intraoral piezo screen held on thelingual aspect of the alveolus. The screen has 64 sensors which detectelectrical changes in the screen as sound distorts it. The test ispremised on the assumption that sound traveling through LBD (low bonedensity) becomes attenuated, hitting the receptor screen with lessintensity than sound which has traveled through normal bone. The speedof sound is also diminished and so changes in speed are captured andaccounted for by the device.

All initial and follow-up QUS scans of alveolar bone were blindly andindependently graded, after calibration, by two investigators accordingto an established 5-point scale, and the following results were shown(Table 1):

TABLE 1 Grading categories for individual 3-D cube images (64 columns ineach) of the Cavitat QUS images. QUS Grade * Description ** 0 “Greenbone.” Cube shows no loss of column height and is 100% green; or mildloss of column height in less than ¼ of columns (16 columns); and/ormoderate to severe loss of column height in less than 4 non-adjacentcolumns. I Cube shows mild loss of column height in more than ¼ ofcolumns; and/or moderate loss of column height in 1/16 to ¼ of thecolumns (5-16 columns); and/or severe loss of height in 1/16 to ⅛ of thecolumns (5-8 columns). II Cube shows moderate loss of column height in ¼to ½ of columns (17-32 columns); and/or severe loss of height in ⅛ to ¼of columns (8-16 columns). III Cube shows moderate loss of column heightin more than ½ of columns (32 columns); and/or severe loss of columnheight in ¼ to ½ of columns (17-32 columns). IV Cube shows severe lossof column height in more than ½ of columns (32 columns). * high gradelesion = Grade III and IV scans; low-grade lesion = Grade I and IIscans; “green bone” = normal or Grade 0 scan ** definition of loss ofcolumn height: mild (crown is green, less than ⅓ loss of height);moderate (crown is yellow or brown, ⅓ to ⅔ loss of height); severe(crown is orange or red, more than ⅔ loss of height)

In case of differences, a consensus grade was arrived at via discussionbetween the two. QUS grades of positive scans, i.e. scans with gradesI-IV before LED therapy were compared with post-therapy scan gradesusing matched pair analysis.

Patients were treated using the a device made in accordance with thepresent invention, the investigational OsseoPulse™ (Version 1.0) device(made by Biolux Research Ltd., Vancouver, Canada). The device consistsof an extra-oral array of highly-efficient light emitting diodes (LED)producing non-coherent continuous wave monochromatic light in thevisible far red (660 nm @ 15 mW/cm2) and infra-red range (840 nm @ 20mW/cm2). In addition, there was an integral alignment device used toensure that the LED array was repeatably and accurately positioneddirectly over the treatment sites. The OsseoPulse device was placed onthe facial surface for 15 minutes daily, 5 days a week for 12 weeks oneach treatment side. The dose per session per treatment area wasapproximately 200 Joules per square inch.

Of 1,148 pre-treatment QUS jawbone scans, each representing the area ofone tooth, 294 were positive for damaged or abnormal bone. Using the5-point scale (0=normal; 4=most severe), half of these sites were lowgrade, i.e. grades 1 or 2, with half being high grade (Table 2):

TABLE 2 Results of 294 QUS scans before and after 3 months of daily LEDphotobiomodulation. Grade Level * # at Pre-Treatment # at Post-Treatment1 79 120 2 69 54 3 86 53 4 61 40 Mean: 2.43 1.33 * 1 = mildLBD/dehydration; 4 = severe LBD/dehydration

The average grade for all 294 positive sites was 2.43. After LEDphotomodulation the average grade was 1.33 and almost 42% ofinvestigated sites had returned to completely normal bone, while another54 (18.4%) sites were grade 1 after therapy (Table 2). One would expectthat the lower the pre-treatment grade, the larger would be theproportion which returned to normal, since it takes a much greater gradeimprovement to reach normal from the higher grades. This proved to bethe case: regions with pre-treatment grades of 1, 2, 3 and 4 returned togreen bone 68.4%, 46.4%, 30.2% and 13.3% of the time, respectively(Table 3):

TABLE 3 Post-treatment changes for each pre-treatment grade level, 294QUS scans. Number of Sites Number @ Grade for each Site at Grade atPost-Treatment* Avg. Level* Pre-Treatment 0** 1** 2** 3** 4** Change 179 54 15 8 2 0 −0.54 2 69 32 19 12 4 2 −1.32 3 86 26 17 22 16 5 −1.50 460 8 3 10 18 21 −1.32 Mean: 2.43 120 54 52 40 28 −1.11 *1 = mildLBD/dehydration; 4 = severe LBD/dehydration (see Table 1) **Representsgrade levels, 0-4, as described in Table 1

Almost 71% of the 294 treated sites demonstrated improvement of at leastone QUS grade level, with most of those, 43.4%, dropping by one grade.The post-treatment grade change was relatively uniform all eachpretreatment QUS grade level (Table 3). Overall the mean difference,i.e. improvement of bone quality, of −1.11 was very statisticallysignificant (matched pair analysis: Std error 0.06914; t-Ratio −15.9896;DF 293; prob [t] less than 0.0001; 95% confidence interval 0.558-1.242).

While in the foregoing specification this invention has been describedin relation to certain preferred embodiments thereof, and many detailshave been set forth for the purpose of illustration, it will be apparentto those skilled in the art that the invention is susceptible toadditional embodiments and that certain details described herein can bevaried considerably without departing from the basic principles of theinvention. For example:

-   -   Light therapy apparatus 34 may be applied for treatment and        stimulation of other bone or soft tissues, such as the hip. In        such applications, light source 35 can be attached to a        treatment area with an adhesive such as double-sided adhesive        tape (not shown). Alternatively, the external light therapy        apparatus 34 can be placed or sewn into a pouch, undergarment or        similar garment and attached to the treatment area through means        of a strap, button or similar attaching means (not shown).    -   It is not mandatory that a controller be programmable. For        example, a controller may have controls that allow various        parameters to be set. A physician, therapist or technician may        set those controls so that an appropriate treatment is delivered        when a patient initiates delivery of the treatment.    -   Features or components described in relation to one of the        embodiments described herein may be provided in combination with        components or features of other ones of the example embodiments        described herein. For example, the controller 15 shown in FIG. 6        could be used in conjunction with any of the described        embodiments. Light sources having a property or properties like        those of the light source 4 shown in the embodiments of FIGS. 1        to 1C could be applied in other embodiments.        It is therefore intended that the following appended claims and        claims hereafter introduced are interpreted to include all such        modifications, permutations, additions and sub-combinations as        are within their true spirit and scope.

1. A method for preparing an apparatus useful for delivering lighttherapy to jaw tissues of a patient, the method comprising: coupling anextra-oral light source to a support; fitting the support to registerwith one or more anatomical features of the patient's head; and aligningthe light source toward the patient's facial skin covering the patient'sjaw bone or soft tissue.
 2. The method according to claim 1 whereinfitting the support comprises inserting an intra-oral tray into thepatient's mouth.
 3. The method according to claim 1 wherein fitting thesupport comprises adjusting a head set to register with the bridge ofthe patient's nose and the patient's ears.
 4. A method for administeringphototherapy to tissues of the jaw bone or soft tissue of a patient, themethod comprising: directing a light source toward the face of thepatient; allowing the light source to emit light; and allowing the lightto pass through the patient's facial skin covering the patient's jawbone to irradiate target tissues in one or more of the patient's jawbone or soft tissue.
 5. The method according to claim 4 whereindirecting the light source comprises registering a frame to anatomicalfeatures of the patient's head and supporting the light source on theframe.
 6. The method according to claim 4 wherein the emitted lightcomprises light in the wavelength range of about 820 to about 890 nm orabout 620 to about 680 nm.
 7. The method according to claim 4 whereinthe emitted light comprises light in the wavelength ranges of: 613 nm to624 nm, 667 nm to 684 nm, 750 nm to 773 nm, or 812 nm to 846 nm.
 8. Themethod according to claim 4 wherein the emitted light comprises light ofa wavelength corresponding to an absorption band of cytochrome coxidase.
 9. The method according to claim 8 wherein the absorption bandis an absorption band of reduced cytochrome c oxidase.
 10. The methodaccording to claim 8 wherein the absorption band is an absorption bandof oxidized cytochrome c oxidase.
 11. The method according to claim 4comprising allowing the light source to contact the skin of thepatient's face.
 12. The method according to claim 4 wherein allowing thelight source to emit light comprises allowing the light source to emitpulses of light.
 13. The method according to claim 12 wherein theemitted light has a time-averaged intensity of at least about 10 mW/cm²at a light-emitting surface of the light source over a period of atleast 10 seconds.
 14. The method according to claim 13 wherein thetime-averaged intensity is in the range of 20 mW/cm² to about 60 mW/cm².15. The method according to claim 4 wherein the emitted light comprisesvisible and infrared light.
 16. The method according to claim 15 whereina ratio of the intensity of the visible light to the infrared light is 1part or less visible light to 5 parts or more infrared light.
 17. Themethod according to claim 4 comprising allowing the light source to emitlight for a period determined by an automatic timer.
 18. The methodaccording to claim 4 comprising: prior to allowing the light source toemit light, forming the light source support to conform to contours ofthe face of the patient; and while allowing the light source to emitlight, urging the light source against the face of the patient.
 19. Amethod for treating a jaw bone disorder, comprising the steps of:contacting at least one extra-oral light source against skin the face ofa patient in need of jawbone-disorder treatment; and administering tothe patient an effective amount of the light through the patient's faceto the patient's jaw or gums.
 20. The method of claim 19 furthercomprising placing into the patient's mouth an intra-oral tray, theintra-oral tray being connected to an extra-oral bridge that isconnected to the at least one extra-oral light source.
 21. The method ofclaim 19 wherein the extra-oral light source is an extra-oral LED array.22. The method of claim 19 wherein the emitted light comprises light inthe wavelength range of about 820 to about 890 nm or about 620 to about680 nm.
 23. The method of claim 19 wherein the emitted light compriseslight in the wavelength ranges: 613 nm to 624 nm, 667 nm to 684 nm, 750nm to 773 nm, or 812 nm to 846 nm.
 24. The method of claim 19 furthercomprising rotating the at least one extra-oral light source between asagittal axis and a vertical axis.
 25. The method of claim 19 whereinthe jaw bone disorder is jaw osteonecrosis.
 26. A method forbiostimulating bone or soft tissue comprising the steps of: contactingat least one extra-oral light source against skin the face of a patientin need of jawbone-disorder treatment; and administering to the patientan effective amount of the light through the patient's face to thepatient's jaw or gums.
 27. The method of claim 26 further comprisingplacing into the patient's mouth an intra-oral tray, the intra-oral traybeing connected to an extra-oral bridge that is connected to the atleast one extra-oral light source.
 28. The method of claim 26 whereinthe extra-oral light source is an extra-oral LED array.
 29. The methodof claim 26 wherein the emitted light comprises light in the wavelengthrange of about 820 to about 890 nm or about 620 to about 680 nm.
 30. Themethod of claim 26 wherein the emitted light comprises light in thewavelength ranges: 613 nm to 624 nm, 667 nm to 684 nm, 750 nm to 773 nm,or 812 nm to 846 nm.
 31. The method of claim 26 further comprisingrotating the at least one extra-oral light source between a sagittalaxis and a vertical axis.
 32. The method of claim 26, wherein thepatient was subjected to oral or periodontal surgery.
 33. The method ofclaim 32, wherein the biostimulation results in the acceleration ofpost-oral surgery healing or post-periodontal surgery healing.
 34. Themethod of claim 26, wherein the patient has an endosseous dentalimplant.
 35. The method of claim 34, wherein the biostimulation resultsin the acceleration of osseointegration of endosseous dental implants.36. The method of claim 26, wherein the method is used in orthodontics.37. The method of claim 26 wherein the at least one extra-oral lightsource comprises optics which focus the light emitted from the at leastone extra-oral light source at an angle approximately between 45-60°.38. A method for orthodontic treatment, comprising the steps of:contacting at least one extra-oral light source against skin the face ofa patient in need of jawbone-disorder treatment; and administering tothe patient an effective amount of the light through the patient's faceto the patient's jaw or gums.
 39. The method of claim 38, wherein theemitted light comprises light in at least one of the wavelength ranges:613 nm to 624 nm, 667 nm to 684 nm, 750 nm to 773 nm, 812 nm to 846 nm,between about 820 to about 890 nm, and between about 620 to about 680nm.
 40. The method of claim 19, 26, or 38 wherein the extra-oral lightsource contacts a side of the person's face.
 41. The method of claim 19,26, or 38 wherein the light is substantially monochrome.
 42. The methodof claim 19, 26, or 38 wherein the light is pulsed.
 43. The method ofclaim 19, 26, or 38 wherein the light has an average intensity of atleast about 10 mW/cm².
 44. The method of claim 19, 26, or 38 wherein thelight has an average intensity in the range of 10 mW/cm² to about 60mW/cm².
 45. The method of claim 19, 26, or 38 wherein the light has anaverage intensity in the range of 20 mW/cm² to about 60 mW/cm².
 46. Themethod of claim 19, 26, or 38 wherein the light has a peak intensityhigher than 50 mW/cm².
 47. The method of claim 19, 26, or 38 wherein thelight radiates from a plurality of extra-oral light sources that contactthe patient's face.
 48. The method of claim 47 wherein the light passesthrough the left and right sides of the facial skin covering thepatient's jaw bone.
 49. The method of claim 19, 26, or 38 furthercomprising cooling the extra-oral light sources with a thermal coolingsystem.
 50. The method of claim 49 wherein the thermal cooling system isconfigured for forced air or liquid cooling.
 51. The method of claim 49wherein the thermal cooling system comprises a heat sink.
 52. The methodof claim 19, 26, or 38, further comprising programming a controller todirect the at least one extra-oral light source to emit light, whereinthe controller is programmed to direct the extra-oral light source toemit light at predetermined rates, durations of treatment, lightintensity, or pulse frequency according to a prescribed treatmentregimen.
 53. The method of claim 52 wherein the controller comprises afail-safe circuitry that shuts off current and light if heat from theextra-oral light source exceeds a preset level.
 54. The method of claim38 wherein the extra-oral light source is an extra-oral LED array. 55.The method of claim 19, 26, or 38 wherein the extra-oral light sourcecomprises a laser.
 56. The method of claim 54 wherein the extra-oral LEDarray capable of illuminating both upper and lower jaws of the patientsimultaneously.
 57. The method of claim 19, 26, or 38 wherein the lightcomprises multiple wavelengths.
 58. The method of claim 19, 26, or 38wherein the light comprises visible and infrared light.
 59. The methodof claim 58 wherein a ratio of the intensity of the visible light to theinfrared light is 1 part or less visible light to 5 parts or moreinfrared light.
 60. The method of claim 42 wherein the light is pulsedwith a duty cycle of 1:2 (on:off, respectively) or less.
 61. The methodof claim 19, 26, or 38 wherein the extra-oral light source furthercomprises optics or reflectors to direct the light emitted from theextra-oral light source.
 62. The method of claim 61 wherein the opticsor reflectors are encapsulated in plastic.
 63. The method of claim 19,26, or 38 wherein the light is emitted by another extra-oral lightsource, wherein one extra-oral light source contacts the right side ofthe patient's face, and the other extra-oral light source contacts theleft side of the patient's face.
 64. The method of claim 19, 26, or 38wherein the extra-oral light source attached to a head set.
 65. Themethod of claim 64 wherein the head set comprises a frame adapted to fiton the bridge of the patient's nose.
 66. The method of claim 65 whereinthe frame has arms that fit above and around the patient's ears.
 67. Themethod of claim 64 further comprising attaching the extra-oral lightsource to the head set or detaching the extra-oral light source from thehead set.
 68. The method of claim 67 wherein the extra-oral light sourceis attached by inserting a male portion of the extra-oral LED lightsource into a female portion of the head set.
 69. The method of claim 64further comprising adjusting the position of the extra-oral light sourcealong a horizontal axis relative to the head set or a vertical axisrelative to the head set.
 70. The method of claim 69 wherein theposition of the extra-oral light source is adjusted by loosening screws,sliding a yoke to a desired position along a slot, and retightening thescrews.
 71. The method of claim 70 wherein the slot follows thecurvature of a maxillary bone.
 72. The method of claim 38, furthercomprising rotating the extra-oral light source between a sagittal axisand a vertical axis.
 73. The method of claim 52, wherein the controllerseparately controls a first light source with an upper level and asecond light source with lower level of light emitters, wherein theupper level and lower levels irradiate tissues of upper and lower jaws,respectively, of the patient when in use.
 74. The method of claim 52,wherein the controller maintains a log of treatments that have beenadministered.